Pharmacy Kit, Starter Pack, Tandem Mobi, Control-IQ+

GUDID 00389152493671

Pharmacy Kit, Starter Pack, Tandem Mobi, Control-IQ+

Tandem Diabetes Care, Inc.

Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Primary Device ID00389152493671
NIH Device Record Key8f46dd41-9812-4026-993a-5b972a21f959
Commercial Distribution StatusIn Commercial Distribution
Brand NamePharmacy Kit, Starter Pack, Tandem Mobi, Control-IQ+
Version Model Number1014936
Company DUNS827900809
Company NameTandem Diabetes Care, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100389152493671 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QFGAlternate Controller Enabled Insulin Infusion Pump

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-21
Device Publish Date2025-03-13

Devices Manufactured by Tandem Diabetes Care, Inc.

00389152470641 - Tandem t:slim Mobile Application, Android2025-03-24 Tandem t:slim Mobile Application, Android
00389152470740 - t:slim Mobile Application, iOS2025-03-24 Tandem t:slim Mobile Application, iOS version 2.9
00389152493671 - Pharmacy Kit, Starter Pack, Tandem Mobi, Control-IQ+2025-03-21Pharmacy Kit, Starter Pack, Tandem Mobi, Control-IQ+
00389152493671 - Pharmacy Kit, Starter Pack, Tandem Mobi, Control-IQ+2025-03-21 Pharmacy Kit, Starter Pack, Tandem Mobi, Control-IQ+
00389152407012 - t:slim X2 Insulin Pump with Control-IQ+ Technology2025-01-30 Control-IQ 7.x
00389152407111 - t:slim X2 Insulin Pump with Control-IQ+ Technology2025-01-30 Control-IQ+ 7.x, Medicare
00389152407210 - t:slim X2 Insulin Pump with Control-IQ+ Technology2025-01-30 Control-IQ+ 7.x, Replacement
00389152407319 - t:slim X2 Insulin Pump with Control-IQ+ Technology2025-01-30 Control-IQ+ 7.x, Refurbished
00389152559575 - Tandem Mobi Autosoft XC Kit2024-12-31 Autosoft XC, 5"/6mm, 14 pack kit

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